Quality Systems Engineer - Health

Summary

The  Health group is seeking a meticulous and experienced Quality Systems Engineer to join our team. In this role, you will be responsible for planning, executing, and documenting the validation of software systems to ensure they meet specified requirements for cross-functional teams and regulatory standards. This includes both custom-developed and third-party software used in product development, manufacturing, and business operations.

If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers’ hands.

Come join our team!

Description

The Quality Systems Engineer will develop and execute regulated non-product software systems validation in accordance with applicable regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485), while collaborating with cross-functional teams including developers, vendors, QA, regulatory affairs, and system users to define validation requirements and acceptance criteria. This person will analyze business and system requirement specifications to ensure testability and compliance with intended use.

Responsibilities

Conduct risk assessments and define validation scope and testing strategies.
Perform software testing (functional, regression, and user acceptance) as part of validation activities.
Document test results, deviations, and nonconformances, and work with stakeholders to resolve issues.
Ensure traceability of requirements through validation documentation.
Maintain validation documentation to support audits and inspections.
Work with cross-functional team members to model Quality processes in quality management software systems.
Complete and support end-to-end verification of automated Quality processes to ensure compliance with applicable standards.
Ensure that systems conform to data protection schemes for handling of sensitive data.
Implement and maintain system integrations between regulated and enterprise non-product software systems.

Minimum Qualifications

B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
3+ years of medical device experience in a quality/regulatory role
Familiarity with 21 CFR Part 11, 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
Experience working on software products within a quality or regulatory system
Experience interpreting requirements and following standard operating procedures
Experience with electronic Quality Management Systems including Post Market Surveillance / Complaint Handling
Exceptional organizational and leadership skills
Ability to be onsite weekly; this role is a hybrid, in-person position.

Preferred Qualifications

Expertise in execution of design controls
Proven background in being autonomous and being able to clearly work towards establishing goals and initiatives with minimal oversight
Demonstrated competence in determining appropriate global regulatory requirements for new products or product changes
Excellent communication skills, both verbal and written

Pay & Benefits — Cupertino, California, United States

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $120,900 and $201,400, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses — including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

Application Deadline

Apple accepts applications to this posting on an ongoing basis.